Santalis Pharmaceuticals, a clinical-stage biopharmaceutical company developing innovative therapies for oncology supportive care and dermatology applications, is pleased to announce that the first subject has been enrolled in an open-label Phase 2 trial for the prevention of oral mucositis, testing an oral rinse formulation of the company’s novel botanical drug candidate, East Indian Sandalwood Oil (EISO).

Oral mucositis, a common side effect of many cancer chemotherapy and radiation treatments, is characterized by debilitating inflammation and ulcerations of the mouth and throat. This problem afflicts approximately 450,000 patients each year in the United States and can affect the course and outcome of cancer therapy. In some cancers, such as head and neck cancers, nearly every patient that receives radiotherapy will develop oral mucositis. There are few FDA-approved drugs for the prevention of oral mucositis and there is a need for more effective and safer products to treat this serious condition. In other laboratory and clinical evaluations, EISO has demonstrated strong anti-inflammatory activity, favorable tolerability, as well as the ability to control the growth of yeast and other micro-organisms that cause secondary infections in those with oral mucositis.

EISO is being evaluated in an open-label proof-of-concept Phase 2 trial for its safety, tolerability and efficacy in preventing oral mucositis in up to 15 subjects who are undergoing radiotherapy for the treatment of head and neck cancer (with or without chemotherapy). Accrual of subjects to the study is on-going and completion is expected in 2016.

“We believe that our EISO-based treatment has the potential to address a significant unmet medical need for the hundreds of thousands of patients that suffer from oral mucositis each year,” commented Dr. Paul Castella, Chief Executive Officer at Santalis. “Oral mucositis causes significant discomfort and pain in many patients, and because of the lack of effective treatments, may delay or interrupt the patient’s essential cancer treatment.”

About Oral Mucositis

Oral Mucositis (OM) is an acute inflammation and ulceration of the surface of the mouth and throat in cancer patients caused by chemotherapy and radiation treatment, which disrupt rapidly dividing epithelial progenitor cells. It is estimated that approximately 450,000 cases of OM are diagnosed annually. OM can be an intensely painful condition that often leads to difficulties swallowing food and fluids, potentially leading to dehydration and malnutrition. OM can also lead to delays in cancer treatments, through chemotherapy dose reductions, breaks in radiation treatment, cessation of cancer therapy, hospitalization and reliance on parenteral nutrition. There are limited treatment options once OM is established and prevention is a major medical and patient unmet medical need. OM is seen most often in patients receiving radiation therapy for head and neck cancer, and in patients receiving high-dose chemotherapy conditioning prior to hematopoietic stem cell transplantation. However, any patient receiving cancer treatment is at risk.

ABOUT SANTALIS PHARMACEUTICALS

Santalis Pharmaceuticals, Inc. is a wholly-owned subsidiary of TFS Corporation, Ltd. (ASX: TFC). Santalis, and its sister company, ViroXis, were acquired by TFS in July 2015 and are developing scientifically and clinically validated over the counter and prescription products that utilize TFS’ cultivated, sustainable, pharmaceutical-grade East Indian Sandalwood Oil. Santalis’ product development programs are focused in oral health and dermatology, where EISO’s well documented safety and anti-infective, anti-proliferative and anti-inflammatory properties are well suited to a number of prevalent and under-served conditions (such as acne, eczema, psoriasis, oral mucositis, onychomycosis, HPV skin warts and Molluscum Contagiosum). In addition to the oral mucositis study, Santalis has ongoing Phase 2 studies in pediatric Molluscum contagiosum, pediatric atopic dermatitis (eczema) and psoriasis, and is preparing to initiate a Phase 3 study for pediatric HPV skin warts.

ABOUT INDIAN SANDALWOOD

Indian sandalwood has a history as a tradeable commodity spanning thousands of years, but is now endangered due to the illegal harvest of wild trees throughout the world. As a result, Indian sandalwood is the world’s most expensive tropical hardwood.

Indian sandalwood oil is a globally important ingredient in fine fragrances, cosmetics and toiletries, Indian consumer products and for medicinal purposes (Ayurvedic and Chinese medicine) and the wood is used for high quality carvings and artefacts and religious worship in the Hindu and Buddhist faiths. Due to the efficacy and safety profile of EISO, the global pharmaceutical market has the potential to be a significant consumer of Indian sandalwood.